Over the last 25 years, a small but growing body of research on research behavior has slowly provided a more complete and critical understanding of research practices, particularly in the biomedical and behavioral sciences. The results of this research suggest that some earlier assumptions about irresponsible conduct are not reliable, leading to the conclusion that there is a need to change the way we think about and regulate research behavior. This paper begins with suggestions for more precise definitions of the terms "responsible conduct of research," "research ethics," and "research integrity." It then summarizes the findings presented in some of the more important studies of research behavior, looking first at levels of occurrence and then impact. Based on this summary, the paper concludes with general observations about priorities and recommendations for steps to improve the effectiveness of efforts to respond to misconduct and foster higher standards for integrity in research.Researchers should practice research responsibly. Unfortunately, some do not. For the past 25 years, following public reports of major cases of irresponsible conduct, policy makers and the research community have been debating how to label, study, and respond to research behaviors that fall short of responsible conduct.The consensus that emerged from these debates broadly separated research behaviors in to three categories: deliberate misconduct, commonly defined as fabrication, falsification, and plagiarism (FFP); questionable research practices (QRP);
This article discusses the key decisions and steps that have partially formalized instruction in the responsible conduct of research (RCR) in U.S. research institutions, the different purposes for offering and/or requiring such instruction, and suggestions for what needs to be done to enhance the professional development of researchers in the future. RCR education has developed during three distinct eras: the 1980s, when policy makers were most concerned with defining and investigating research misconduct; the 1990s, when there was significant but highly decentralized growth in RCR instruction; and the years since 2000, when there have been a series of reforms and educational developments. There is still a need for scientists, universities, and professional societies to develop consensus on best ethical practices in many areas of scientific research. More also needs to be learned about assessing the quality of RCR instruction and the effects of training on researchers' behavior. To help set the course for RCR instruction in the future, more effort and funding need to be directed to studying actual research behavior and the factors that influence it; RCR educators and administrators must develop a common vocabulary and framework for developing and evaluating the impact of RCR instruction; and research institutions and funding agencies alike need to take a more active role in promoting and supporting RCR instruction.
The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortium's Clinical Research Ethics Key Function Committee (CRE-KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8-item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unifi ed approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources.
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